An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951026
• Other study ID #: SM04690-OA-05
• Status: Completed
• Start date: September 19, 2016
• Est. completion date: October 31, 2019

Study information

• Verified date: April 2020
• Source: Samumed LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies

• Full understanding of the requirements of the study and willingness to comply with all study visits and assessments

• Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

• Unable to undergo the radiograph procedures detailed within the protocol

• Partial or complete joint replacement in the target knee

• Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site

• Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Not applicable (no therapy is administered as part of this study)
No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior "parent" study.

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Arlington	Virginia
United States	Research Site	Austin	Texas
United States	Research Site	Bedford	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boulder	Colorado
United States	Research Site	Canoga Park	California
United States	Research Site	Carmichael	California
United States	Research Site	Cerritos	California
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Cleveland	Ohio
United States	Research Site	Coral Gables	Florida
United States	Research Site	DeLand	Florida
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Edgewater	Florida
United States	Research Site	El Cajon	California
United States	Research Site	Frederick	Maryland
United States	Research Site	Gold River	California
United States	Research Site	High Point	North Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Knoxville	Tennessee
United States	Research Site	La Mesa	California
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lauderdale Lakes	Florida
United States	Research Site	Layton	Utah
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Marietta	Georgia
United States	Research Site	Miami	Florida
United States	Research Site	Mount Pleasant	South Carolina
United States	Research Site	Newton	Kansas
United States	Research Site	Orchard Park	New York
United States	Research Site	Oro Valley	Arizona
United States	Research Site	Palm Springs	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rancho Mirage	California
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Rochester	New York
United States	Research Site	Sacramento	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Peters	Missouri
United States	Research Site	Salisbury	North Carolina
United States	Research Site	San Angelo	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Marcos	California
United States	Research Site	Spring Valley	California
United States	Research Site	Stamford	Connecticut
United States	Research Site	Troy	Michigan
United States	Research Site	Trumbull	Connecticut
United States	Research Site	Tucson	Arizona
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Wichita	Kansas
United States	Research Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Samumed LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of serious adverse events (SAEs)	Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60	Month 60
Secondary	Adverse events (AEs) of interest	Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 6. AEs of interest include those related to either knee and/or an AE that is a newly diagnosed chronic condition requiring treatment (e.g., hypertension, hyperlipidemia, diabetes).	Month 6
Secondary	AEs of interest	Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 12.	Month 12
Secondary	AEs of interest	Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 24.	Month 24
Secondary	AEs of interest	Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 36.	Month 36
Secondary	AEs of interest	Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 48.	Month 48
Secondary	AEs of interest	Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 60.	Month 60
Secondary	Incidence and incidence rate of total knee replacement (TKR)	Compare the incidence and incidence rate of TKR in the previously injected knee occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60.	Month 60
Secondary	Change in joint space width (JSW)	Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.	Baseline and Month 6
Secondary	Change in joint space width (JSW)	Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.	Baseline and Month 12
Secondary	Change in joint space width (JSW)	Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.	Baseline and Month 24
Secondary	Change in joint space width (JSW)	Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.	Baseline and Month 36
Secondary	Change in joint space width (JSW)	Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.	Baseline and Month 48
Secondary	Change in joint space width (JSW)	Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.	Baseline and Month 60
Secondary	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score	Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.	Baseline and Month 6
Secondary	Change in WOMAC total score	Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.	Baseline and Month 12
Secondary	Change in WOMAC total score	Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.	Baseline and Month 24
Secondary	Change in WOMAC total score	Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.	Baseline and Month 36
Secondary	Change in WOMAC total score	Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.	Baseline and Month 48
Secondary	Change in WOMAC total score	Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.	Baseline and Month 60
Secondary	Change in WOMAC pain subscore	Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.	Baseline and Month 6
Secondary	Change in WOMAC pain subscore	Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.	Baseline and Month 12
Secondary	Change in WOMAC pain subscore	Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.	Baseline and Month 24
Secondary	Change in WOMAC pain subscore	Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.	Baseline and Month 36
Secondary	Change in WOMAC pain subscore	Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.	Baseline and Month 48
Secondary	Change in WOMAC pain subscore	Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.	Baseline and Month 60
Secondary	Change in WOMAC function subscore	Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.	Baseline and Month 6
Secondary	Change in WOMAC function subscore	Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.	Baseline and Month 12
Secondary	Change in WOMAC function subscore	Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.	Baseline and Month 24
Secondary	Change in WOMAC function subscore	Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.	Baseline and Month 36
Secondary	Change in WOMAC function subscore	Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.	Baseline and Month 48
Secondary	Change in WOMAC function subscore	Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.	Baseline and Month 60
Secondary	Change in Physician Global Assessment	Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.	Baseline and Month 6
Secondary	Change in Physician Global Assessment	Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.	Baseline and Month 12
Secondary	Change in Physician Global Assessment	Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.	Baseline and Month 24
Secondary	Change in Physician Global Assessment	Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.	Baseline and Month 36
Secondary	Change in Physician Global Assessment	Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.	Baseline and Month 48
Secondary	Change in Physician Global Assessment	Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.	Baseline and Month 60
Secondary	Change in Patient Global Assessment	Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.	Baseline and Month 6
Secondary	Change in Patient Global Assessment	Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.	Baseline and Month 12
Secondary	Change in Patient Global Assessment	Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.	Baseline and Month 24
Secondary	Change in Patient Global Assessment	Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.	Baseline and Month 36
Secondary	Change in Patient Global Assessment	Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.	Baseline and Month 48
Secondary	Change in Patient Global Assessment	Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.	Baseline and Month 60